Table 1.
Patients baseline demographics and clinical characteristics
| A is patients baseline demographics and clinical characteristics in single dose study | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Step | Placebo | Step 1 | Step 2 | Step 3 | Step 4 | Step 5 | Step 6 | Step 7 | |
| Dose | (Step 1–7) | 0.025 mg | 0.05 mg | 0.1 mg | 0.2 mg | 0.4 mg | 0.6 mg | 0.8 mg | |
| Number of patients (n) | 15 | 4 | 4 | 4 | 4 | 4 | 4 | 5 | |
| Age (years) | 58.9 ± 10.2 | 59.5 ± 10.5 | 60.0 ± 12.9 | 59.0 ± 7.5 | 57.8 ± 8.2 | 67.5 ± 10.1 | 62.0 ± 5.1 | 63.0 ± 9.8 | |
| BMI (kg/m2) | 24.57 ± 4.04 | 21.01 ± 3.13 | 20.71 ± 2.27 | 26.23 ± 4.15 | 26.28 ± 2.85 | 22.27 ± 3.45 | 21.95 ± 4.04 | 26.01 ± 3.61 | |
| Dry weight (kg) | 68.96 ± 14.05 | 58.93 ± 9.91 | 51.23 ± 7.49 | 70.25 ± 11.74 | 76.40 ± 6.21 | 57.83 ± 11.29 | 62.20 ± 14.67 | 65.00 ± 22.71 | |
| Duration of dialysis (years) | 8.82 ± 8.18 | 9.53 ± 7.68 | 13.05 ± 5.18 | 2.44 ± 2.72 | 8.02 ± 2.49 | 3.21 ± 1.75 | 16.26 ± 8.98 | 5.74 ± 5.12 | |
| Dialysate calcium concentration | 2.5 mEq/L | 2 (13.3) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) |
| 2.75 mEq/L | 7 (46.7) | 3 (75.0) | 2 (50.0) | 2 (50.0) | 4 (100.0) | 1 (25.0) | 3 (75.0) | 2 (40.0) | |
| 3.0 mEq/L | 6 (40.0) | 1 (25.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 3 (75.0) | 1 (25.0) | 2 (40.0) | |
| Serum iPTH (pg/mL) | 510.3 ± 232.2 | 394.8 ± 229.2 | 486.0 ± 127.7 | 301.5 ± 84.5 | 538.7 ± 172.1* | 267.3 ± 166.7 | 404.5 ± 122.7 | 520.8 ± 207.7 | |
| Serum cCa (mg/dL) | 9.71 ± 0.57** | 9.45 ± 0.37 | 9.35 ± 0.35 | 9.30 ± 0.90* | 9.90 ± 0.22 | 9.53 ± 0.50 | 10.20 ± 0.54 | 9.52 ± 0.84 | |
| Serum P (mg/dL) | 3.56 ± 0.94** | 3.45 ± 0.66 | 3.03 ± 0.51 | 3.57 ± 1.00* | 4.08 ± 0.15 | 3.40 ± 0.50 | 2.98 ± 0.29 | 3.76 ± 1.43 | |
| B is patients baseline demographics and clinical characteristics in multiple dose study | |||||
|---|---|---|---|---|---|
| Step | Placebo | Step 1 | Step 2 | Step 3 | |
| Dose | (Step 1–3) | 0.05 mg | 0.1 mg | 0.2 mg | |
| Number of patients (n) | 11 | 9 | 9 | 10 | |
| Age (years) | 65.2 ± 7.9 | 61.9 ± 8.8 | 53.7 ± 14.1 | 56.2 ± 9.8 | |
| BMI (kg/m2) | 23.41 ± 3.73 | 22.63 ± 2.98 | 22.58 ± 2.83 | 23.91 ± 4.13 | |
| Dry weight (kg) | 62.68 ± 13.82 | 60.52 ± 12.18 | 59.70 ± 10.84 | 65.34 ± 12.75 | |
| Duration of dialysis (years) | 12.09 ± 8.19 | 8.61 ± 5.67 | 10.73 ± 13.48 | 6.69 ± 4.29 | |
| Dialysate calcium concentration | 2.5 mEq/L | 1 (9.1) | 4 (44.4) | 1 (11.1) | 2 (20.0) |
| 2.75 mEq/L | 6 (54.5) | 4 (44.4) | 1 (11.1) | 5 (50.0) | |
| 3.0 mEq/L | 4 (36.4) | 1 (11.1) | 7 (77.8) | 3 (30.0) | |
| Serum iPTH (pg/mL) | 368.8 ± 78.9 | 439.0 ± 259.9* | 507.5 ± 226.4* | 393.7 ± 210.4 | |
| Serum cCa (mg/dL) | 9.92 ± 0.70 | 9.43 ± 0.68* | 9.46 ± 0.81* | 9.49 ± 0.63 | |
| Serum P (mg/dL) | 5.64 ± 1.43 | 6.33 ± 0.97* | 5.26 ± 1.14* | 6.00 ± 1.23 | |
A: Mean ± SD, or number of patients (%) *n = 3, **n = 14
B: Mean ± SD, or number of patients (%) *n = 8